NCT03343262

Brief Summary

Impaired Glucose Tolerance (IGT) is an abnormal metabolic state following glucose metabolic steady state but prior to diabetes. IGT is an important stage during the progression of diabetes, with an underlying mechanism of insulin resistance and pancreatic β cell dysfunction. IGT is one of the diseases that shows significant beneficial response to acupuncture treatment. Original findings from the investigators'laboratory show that transcutaneous auricular vagus nerve stimulation (taVNS) which is innervated by vagus nerve, would enhance the activity of pancreatic β cells, promote the secretion of insulin, upregulate the expression of insulin receptors in central as well as peripheral tissues, thus to improve glycometabolism. In this study, the investigators would further illuminate the mechanism of taVNS at "yidan-pi" auricular acupoints on the regulation of glucose metabolism, its improvement of the IGT state in rat model, as well as its regulation effect on insulin receptor expression and insulin resistance, and systematically illustrate the clinical effective of this treatment on IGT, with emphasize on its influence on the concentrations of glucose and HbA1c, and thus provide an effective proposal for clinical acupuncture.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 22, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

October 30, 2017

Last Update Submit

November 21, 2017

Conditions

Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (2)

  • FPG

    The fasting plasma glucose (FPG) is used to diagnose diabetes. IGT can be diagnosed base on FPG less than 7.0 mmol/L.

    Baseline and 6 week, 12 weeks

  • OGGT

    The 2-hour plasma glucose after a 75-g oral glucose tolerance test (OGTT) is used to diagnose diabetes. IGT can be diagnosed base on 2-hour plasma Glucose between 7.8 and 11.1 mmol/L.

    Baseline and 6 week, 12 weeks

Secondary Outcomes (2)

  • BMI

    Baseline and 12 weeks

  • A1C

    Baseline and 6 week,baseline and 12 weeks

Other Outcomes (4)

  • pulse

    Baseline and 12 weeks

  • respiration

    Baseline and 12 weeks

  • blood pressure

    Baseline and 12 weeks

  • +1 more other outcomes

Study Arms (2)

ta-VNS "yidan-pi"

EXPERIMENTAL

Device:ta-VNS \& Electro-acupuncture("yidan-pi" auricular acupoints):2 times per day,2 days per week for 12 weeks

Device: ta-VNSOther: Electro-acupuncture

ta-VNS "jian"

PLACEBO COMPARATOR

Device:ta-VNS \& Electro-acupuncture("jian" auricular acupoints):2 times per day,2 days per week for 12 weeks

Other: Electro-acupuncture

Interventions

ta-VNSDEVICE

The transcutaneous vagus nerve stimulation (taVNS) at auricular concha is a typical representative of TCM modernization. The taVNS regulates the autonomic nervous system, which shows a good therapeutic effect for the treatment of IGT.

Also known as: transcutaneous vagus nerve stimulation
ta-VNS "yidan-pi"
Electro-acupunctureOTHER

one of the most common acupuncture methods, selecting acupoints based on traditional Chinese medicine theory. It exerts the function to regulate qi and blood circulation and balance Yang and Yin energy inside body.

ta-VNS "jian"ta-VNS "yidan-pi"

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages between 20 and 70
  • fasting plasma-glucose(FPG) less than 7 mmol/L, or 2h p-glucose 7.8-11.1 mmol/L
  • anti-diabetic medication of any kind
  • able to provide informed consent

You may not qualify if:

  • comorbidities that would prohibit participation in study procedures, including cardiovascular disease, hematological system disease or psychosis
  • females of childbearing potential who were pregnant, breast-feeding
  • infection within the 1 month
  • known or suspected abuse of alcohol or narcotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Peijing Rong, doctor

    Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Peijing Rong, doctor

CONTACT

0086 01064089302drrongpj@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 17, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

November 22, 2017

Record last verified: 2017-11